Peripheral Artery Disease and Sepsis Outcomes

• Conditions: Peripheral Artery Occlusion; Peripheral Artery Disease; Sepsis; Diagnosis
• Interventions: Drug: Standard care for sepsis; Drug: Standard care for sepsis and PAD

• Registration Number: NCT03372330
• Lead Sponsor: National Taiwan University Hospital Hsin-Chu Branch

Brief Summary

The peripheral artery disease (PAD) prevalence is high in the elderly, the diabetic patients, and the patients receiving hemodialysis. To date, there is no guideline recommendation on the screening of PAD in patients admitted to the medical intensive care unit (MICU) for sepsis.

We conducted a prospective cohort study focusing on patients admitted to the MICU with the main diagnosis of sepsis. The ankle-brachial indexes are performed within 24 hours after admission. Invasive arterial line monitoring and standard non-invasive measurements are collected. After confirmation of PAD, standard anti-platelet treatments (aspirin and cilostazol) are initiated. The survival before and after the conduction of this trial is compared to historical records. The outcomes including all-cause mortality, stroke, myocardial infarction, minor amputation, major amputation, and prolonged ventilator dependent are to be collected.

Detailed Description

This is a prospective observational study focusing on peripheral artery disease (PAD) in patients admitting to intensive care units with a diagnosis of sepsis. The sepsis is defined by the quick SOFA score. The primary outcome is all-cause mortality. The secondary outcomes included stroke, myocardial infarction, amputation, and prolonged mechanical ventilation.

We plan to enroll 150 patients. Patients will be grouped into patients with PAD and patients without PAD. We then compare them in the following parameters: clinical data, laboratory data, survival and other outcome data. Two-sample student's t-tests will be used for the comparisons of continuous variables. Chi-square test will be used to detect the difference between categorical variables. The difference is considered statistically significant if P \< 0.05. All statistics works were analyzed using the SPSS 17.0 software (Chicago, IL, USA), R software (Gimc packages).

Study Timeline

• Study Start: 2017-09-11
• Status Verified: 2017-12
• Study First Submitted: 2017-12-10
• Study First Submitted QC: 2017-12-10
• Last Update Submitted: 2017-12-10
• Study First Posted: 2017-12-13
• Last Update Posted: 2017-12-13
• Primary Completion: 2018-09-10
• Study Completion: 2019-09-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• sepsis patients admitted to the MICU meeting quick SOFA score >= 2 points

Exclusion Criteria

• NA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sepsis without PAD	Standard care for sepsis	Patients admitted to the intensive care unit with the diagnosis of sepsis (quick SOFA score \>=2) and with ankle-brachial index \>= 0.9 or vascular Duplex found no evidence of peripheral artery disease. \* Standard care for sepsis
Sepsis with PAD	Standard care for sepsis and PAD	Patients admitted to the intensive care unit with the diagnosis of sepsis (quick SOFA score \>=2) and with ankle-brachial index \< 0.9 or vascular Duplex confirmed peripheral artery disease. \* Standard care for sepsis and PAD

Primary Outcome Measures

Name	Time	Method
All-cause mortality at 30-day	30 days	All-cause mortality at 30 days

Secondary Outcome Measures

Name	Time	Method
Myocardial infarction	30 days	Myocardial infarction at 30 days
Stroke	30 days	Ischemic stroke at 30 days
Amputation	30 days	Amputation, either major or minor at 30 days

Trial Locations

Locations (1)

National Taiwan University Hospital, Hsin-Chu Branch; 🇨🇳 Hsinchu, Taiwan